Prosthesis deployment system

ABSTRACT

An introducer for an expandable endovascular prosthesis having a self expanding stent has a distal prosthesis positioning mechanism and a proximal prosthesis retention mechanism. The proximal prosthesis retention mechanism includes a cylindrical sleeve adapted to retain the self expanding stent. A release mechanism extends proximally from the distal prosthesis positioning mechanism exerts a force in the proximal direction on the self expanding stent to retain the self expanding stent in the cylindrical sleeve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is Continuation of application Ser. No. 10/930,523,filed Aug. 31, 2004, which is based on and claims all benefits ofProvisional Application Ser. No. 60/503,375 filed Sep. 16, 2003.

BACKGROUND OF THE INVENTION

1. Technical Field

This invention relates to a medical device and, in particular, a methodand means for retaining and releasing an expandable, intraluminalprosthesis for the endovascular repair of diseased or damaged vessels.

Throughout this specification the terms proximal and proximally are usedfor a position or direction towards the patient's heart and the termsdistal and distally are used for a position or direction away thepatient's heart.

2. Related Art

The deployment of intraluminal prostheses into the lumen of a patientfrom a remote location by the use of a deployment device or introducerhas been disclosed in a number of earlier patents and patentapplications. U.S. Pat. No. 4,562,596 entitled “Aortic Graft, Device andMethod for Performing an Intraluminal Abdominal Aortic Aneurysm Repair”,which is herein incorporated by reference, proposes the retention of aself expanding graft within a sleeve until it is to be deployed, atwhich time the sleeve is withdrawn and the graft is allowed to expand.U.S. Pat. No. 4,665,918 entitled “Prosthesis System and Method”, whichis herein incorporated by reference, proposes a system and method forthe deployment of a prosthesis in a blood vessel. The prosthesis ispositioned between a delivery catheter and an outer sheath and expandsoutwardly upon removal of the sheath.

U.S. Pat. No. 4,950,227 entitled “Stent Delivery System”, which isherein incorporated by reference, proposes the delivery of a stent bymounting the stent to the outside of an inflatable catheter andretaining the ends of an unexpanded stent by fitting a sleeve overeither end of the stent. Expansion of the stent is caused by inflationof the catheter between the sleeves so that the ends of the stent arewithdrawn from the respective sleeves and the stent released andexpanded into position.

U.S. Pat. No. 5,387,235 entitled “Endovascular Transluminal Prosthesisfor Repair of Aneurysm”, discloses apparatus and methods of retaininggrafts onto deployment devices. These features and other featuresdisclosed in U.S. Pat. No. 5,387,235 could be used with the presentinvention, and the disclosure of U.S. Pat. No. 5,387,235 is hereinincorporated by reference.

U.S. Pat. No. 5,720,776 entitled “Expandable Transluminal GraftProsthesis for Repair of Aneurysm” discloses improved barbs with variousforms of mechanical attachment to a stent. These features and otherfeatures disclosed in U.S. Pat. No. 5,720,776 could be used with thepresent invention, and the disclosure of U.S. Pat. No. 5,720,776 isherein incorporated by reference.

U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials” disclosesgraft prosthesis materials and a method for implanting, transplantingreplacing and repairing a part of a patient and particularly themanufacture and use of a purified, collagen based matrix structureremoved from a submucosa tissue source. These features and otherfeatures disclosed in U.S. Pat. No. 6,206,931 could be used with thepresent invention, and the disclosure of U.S. Pat. No. 6,206,931 isherein incorporated by reference.

PCT Patent Publication Number No. WO99/29262 entitled “EndoluminalAortic Stents” discloses a fenestrated prosthesis for placement wherethere are intersecting arteries. This feature and other featuresdisclosed in PCT Patent Publication Number No. WO99/29262 could be usedwith the present invention, and the disclosure of PCT Patent PublicationNumber No. WO99/29262 is herein incorporated by reference.

PCT Patent Publication Number No. WO03/034948 entitled “Prostheses forCurved Lumens” discloses prostheses with arrangements for bending theprosthesis for placement into curved lumens. This feature and otherfeatures disclosed in PCT Patent Publication Number No. WO03/034948could be used with the present invention, and the disclosure of PCTPatent Publication Number No. WO03/034948 is herein incorporated byreference.

United States Published Patent Application No. 20030233140 entitled“Trigger Wire System” discloses release wire systems for the release ofstent grafts retained on introducer devices. This feature and otherfeatures disclosed in United States Published Patent Application No.20030233140 could be used with the present invention, and the disclosureof United States Published Patent Application No. 20030233140 is hereinincorporated by reference.

United States Published Patent Application No. 20040098079 entitled“Thoracic Aortic Stent Graft Deployment Device” discloses introducerdevices adapted for deployment of stent grafts particularly in thethoracic arch. This feature and other features disclosed in UnitedStates Published Patent Application No. 20040098079 could be used withthe present invention and the disclosure of United States PublishedPatent Application No. 20040098079 is herein incorporated by reference.

United States Published Patent Application No. 20040054396 entitled“Stent-Graft Fastening” discloses arrangements for fastening stents ontografts particularly for exposed stents. This feature and other featuresdisclosed in United States Published Patent Application No. 20040054396could be used with the present invention, and the disclosure of UnitedStates Published Patent Application No. 20040054396 is hereinincorporated by reference.

PCT Patent Publication Number No. WO03/053287 entitled “Stent Graft withImproved Graft Adhesion” discloses arrangements on stent grafts forenhancing the adhesion of such stent grafts into walls of vessels inwhich they are deployed. This feature and other features disclosed inPCT Patent Publication Number No. WO03/053287 could be used with thepresent invention, and the disclosure of PCT Patent Publication NumberNo. WO03/053287 is herein incorporated by reference.

PCT Patent Publication Number No. WO98/53761 entitled “A Prosthesis anda Method and Means of Deploying a Prosthesis”, which is hereinincorporated by reference, discloses various embodiments of anintroducer for positioning an expandable endovascular prosthesis in alumen of a patient. In one disclosed embodiment, the introducer includesa trigger wire mechanism to control the release of a proximal portion ofthe prosthesis. It would be desirable to provide a method and apparatusto deploy a graft prosthesis that provides a controlled release of aproximal portion of the prosthesis without the need for a trigger wire.

SUMMARY

An introducer for an expandable, endovascular prosthesis with a selfexpanding stent has proximal and distal prosthesis positioningmechanisms. The proximal prosthesis positioning mechanism has acylindrical sleeve and a first control member to selectively disengagethe cylindrical sleeve from the prosthesis. The distal prosthesispositioning mechanism has a distal retention section and a secondcontrol member to selectively disengage the distal retention sectionfrom the prosthesis. The first control member includes a first regioncoupled to the distal prosthesis positioning mechanism that extendslongitudinally therefrom. The first control member also includes asecond region that is coupled to the first region. The second regionselectively and proximally disengages the self expanding stent to retainthe self expanding stent in the cylindrical sleeve.

A method of placing a prosthesis into an internal lumen with aninsertion assembly includes a step of inserting the insertion assemblyincluding the prosthesis into the internal lumen and withdrawing asheath from the insertion assembly to expose the prosthesis. A force isexerted on the prosthesis in a proximal direction by a release mechanismto retain the prosthesis in a prosthesis retention mechanism of theinsertion assembly. The prosthesis retention mechanism is movedproximally away from the release mechanism to release the prosthesisfrom the insertion assembly. The sheath is replaced onto the insertionassembly, and the insertion assembly is retracted.

The invention can be better understood with reference to the followingdrawings and description. The components in the figures are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the invention.

Moreover, in the figures, like referenced numerals designatecorresponding parts throughout the different views.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an introducer with a prosthesispartially deployed.

FIG. 2 is a sectional detail view of a portion of the introducer aroundthe distal end of the prosthesis.

FIG. 3 is a sectional detail view of a portion of the introducer aroundthe proximal end of the prosthesis.

FIG. 4 is a sectional detail view of a portion of the introducer aroundthe haemostatic seal.

FIG. 5 is a sectional detail view of a portion of the introducer aroundthe trigger wire release mechanism.

FIG. 6 is a sectional detail view of the introducer around the pin viseclamp and the medical reagent introduction tube.

FIG. 7 is a sectional view of the introducer of FIG. 1 fully loaded andready for introduction into a patient.

FIG. 8 is a side elevation view, partially in section, of the introducerof FIG. 7 in a first stage of deployment of the prosthesis.

FIG. 9 is a side elevation view, partially in section, of the introducerof FIG. 7 at the release of the proximal end stage of deployment.

FIG. 10 is a side elevation view, partially in section, of theintroducer of FIG. 7 at the release of the distal end stage ofdeployment.

FIG. 11 is a side elevation view, partially in section, of theintroducer of FIG. 7 showing an advancement of the distal attachmentmechanism to the proximal attachment mechanism.

FIG. 12 is a side elevation view, partially in section, of theintroducer of FIG. 7 showing the withdrawal of the introducer fromwithin the expanded prosthesis.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows a prosthesis 20, and an endovascular deployment system,also known as an introducer, for deploying the prosthesis 20 in a lumenof a patient during a medical procedure. The introducer includes anexternal manipulation section 1, a distal positioning mechanism andattachment region 2, and a proximal positioning mechanism and attachmentregion 3. During a medical procedure to deploy the prosthesis 20, thedistal and proximal attachment regions 2 and 3 will travel through thelumen within a patient to a desired deployment site. The externalmanipulation section 1, which is acted upon by a user to manipulate theintroducer, remains outside of the patient throughout the procedure.

The prosthesis 20 comprises a tubular graft material, such as Dacron,with self expanding stents 19 attached thereto. The self expandingstents 19 cause the prosthesis 20 to expand following disengagement fromthe introducer. The prosthesis 20 also includes a self expanding zigzagstent 21 that extends from the prosthesis proximal end. When disengagedfrom the introducer, the self expanding zigzag stent 21 anchors theproximal end of the prosthesis 20 to the lumen.

FIG. 3 shows the proximal attachment region 3 in greater detail. Theproximal attachment region 3 includes a cylindrical sleeve 10. Thecylindrical sleeve 10 has a long tapered flexible extension 11 extendingfrom the sleeve proximal end. The flexible extension 11 has an internallongitudinal aperture 12. The longitudinal aperture 12 facilitatesadvancement of the tapered flexible extension 11 along an insertion wire13. The aperture 12 also provides a channel for the introduction ofmedical reagents. For example, it may be desirable to supply a contrastagent to allow angiography to be performed during placement anddeployment phases of the medical procedure.

A thin walled tube 15, which can be made of metal, is fastened to theextension 11. The thin walled tube 15 is flexible so that the introducercan be advanced along a relatively tortuous vessel, such as a femoralartery. The flexibility of the thin walled tube 15 allows manipulationlongitudinally and rotationally of the proximal attachment region 3. Thethin walled tube 15 extends through the introducer to the manipulationsection 1, terminating at a connection means 16, as shown in FIG. 6.

Regarding the introduction of reagents, FIG. 6 shows that the connectionmeans 16 is adapted to accept a syringe to facilitate the introductionof reagents into the thin walled tube 15. The thin walled tube 15 is influid communication with the aperture 12 of the flexible extension 11.Therefore, reagents introduced into connection means 16 can flow throughthe aperture 12 and emanate from the apertures 14.

As shown in FIG. 2, a tube 41, which can be made of a suitable plastic,is coaxial and radially outside the thin walled tube 15. The tube 41 is“thick walled”, that is to say the thickness of the wall of tube 41 isseveral times that of the thin walled tube 15. A sheath 30 is coaxialand radially outside the thick walled tube 41. The thick walled tube 41and the sheath 30 extend distally to the manipulation region 1, as shownin FIG. 4.

FIGS. 2 and 3 illustrate retention, and distal and proximal releasemechanisms of the introducer, respectively. During the placement phaseof the medical procedure, the prosthesis 20 can be retained in acompressed condition by the sheath 30. The sheath 30 extends distally toa gripping and haemostatic sealing means 35 of the external manipulationsection 1, shown in FIG. 4.

During assembly of the introducer, the sheath 30 can be advanced overthe cylindrical sleeve 10 of the proximal attachment region 3 while theprosthesis 20 is held in a compressed state by an external force. Adistal attachment (retention) section 40 is formed in the thick walledtube 41 to retain the distal end of the prosthesis 20. Alternatively,the distal attachment section 40 can be a separate piece coupled to thethick walled tube 41.

A thin walled cannula 22 is also formed in the thick walled tube 41.Alternatively, the thin walled cannula 22 can be a separate piececoupled to the thick walled tube 41. The thin walled cannula 22 extendsfrom the distal attachment section 40 to a conical tip 23. The conicaltip 23 can be either coupled to the end of the thin walled cannula 22 orformed in the thick walled tube 41. The thick walled tube 41, the thinwalled cannula 22, and the conical tip 23 are each coaxial with andradially outside the thin walled tube 15.

When the prosthesis 20 is in a compressed condition, the self expandingzigzag stent 21 is retained in the cylindrical sleeve 10 by the conicaltip 23. The conical tip 23 asserts pressure on the distal end of theself expanding stent 21 in the proximal direction, holding the selfexpanding zigzag stent 21 in the cylindrical sleeve 10 without the needfor a trigger wire. The self expanding stent 21 is disengaged by firstretracting the sheath 30, and then sliding the proximal attachmentregion 3, including the cylindrical sleeve 10, away from the conical tip23. Once the cylindrical sleeve 10 has cleared the self expanding stent21, the stent 21 will expand. The thin walled cannula 22 and the conicaltip 23 form a control member to selectively disengage the cylindricalsleeve 10 from the prosthesis 20 by exerting force on (pushing) the selfexpanding stent 21 into the cylindrical sleeve 10 until the prosthesis20 is positioned at a desired site in the lumen.

The distal end 42 of the prosthesis 20 is retained by the distalattachment section 40 of the thick walled tube 41. The distal end 42 ofthe prosthesis 20 has a loop 43 through which a distal trigger wire 44extends. The distal trigger wire 44 extends through an aperture 45 inthe distal attachment section 40 into the annular region between thethin walled tube 15 and the thick walled tube 41. As shown in FIG. 5,the distal trigger wire 44 extends through the annular space between thethick walled tube 41 and the thin walled tube 15 to the manipulationregion 1. The distal trigger wire 44 exits the annular space at a distalwire release mechanism 25. The distal trigger wire 44 and the distalwire release mechanism 25 form a control member to selectively disengagethe distal retention section 40 from the prosthesis 20 when it ispositioned at a desired site in a lumen of a patient.

FIG. 4 shows the haemostatic sealing means 35 of the externalmanipulation section 1 shown in greater detail. The haemostatic sealingmeans 35 includes a haemostatic seal 27 a side tube 29. The haemostaticseal 27 includes a clamping collar 26 that clamps the sheath 30 to thehaemostatic seal 27. The haemostatic seal 27 also includes a seal ring28, which can be made of silicone. The seal ring 28 forms a haemostaticseal around the thick walled tube 41. The side tube 29 facilitates theintroduction of medical reagents between the thick walled tube 41 andthe sheath 30.

FIG. 5 shows a proximal portion of the external manipulation section 1.The release wire actuation section has a body 36 that is mounted ontothe thick walled tube 41. The thin walled tube 15 passes through thebody 36. The distal wire release mechanism 25 is mounted for slidablemovement on the body 36. A clamping screw 37 prevents inadvertent earlydisengagement of the distal end 42 of the prosthesis 20. A haemostaticseal 38 is provided so the trigger wire 44 can extend out through thebody 36 to the release mechanism 25 without unnecessary blood lossduring the medical procedure.

FIG. 6 shows a distal portion of the external manipulation section 1. Apin vise 39 is mounted onto the distal end of the body 36. The pin vise39 has a screw cap 46. When screwed in, the vise jaws 47 clamp againstand engage the thin walled tube 15. When the vise jaws 47 are engaged,the thin walled tube 15 can only move with the body 36, and hence thethin walled tube 15 can only move with the thick walled tube 41. Withthe screw cap 46 tightened, the entire assembly, except for the externalsheath 30, can be moved as one.

FIGS. 7 through 12 show the various stages of the deployment of theprosthesis 20 during the medical procedure. A guide wire 13 isintroduced into a lumen such as the femoral artery and advanced untilits tip is beyond the region into which the prosthesis 20 is to bedeployed.

In FIG. 7, the introducer assembly is shown fully assembled ready forintroduction into a patient. The prosthesis 20 is retained at each ofits ends by the proximal and distal retaining assemblies respectively,and compressed by the external sheath 30. If it is an aortic aneurismwhich is to be grafted, the introducer assembly can be inserted througha femoral artery over the guide wire 13 in the form as shown in FIG. 7,and positioned by well-known radiographic techniques (not discussedhere).

In FIG. 8, the introducer assembly is in a desired position fordeployment of the prosthesis 20. The external sheath 30 is withdrawn tojust proximal of the distal attachment section 40. This actiondisengages the middle portion of the prosthesis 20 so that it can expandradially. The proximal self expanding stent 21, however, is stillretained within the cylindrical sleeve 10. Also, the distal end 42 ofthe prosthesis 20 is still retained within the external sheath 30.

By release of the pin vise 39 to allow small movements of the thinwalled tube 15 with respect to the thick walled tube 41, the prosthesis20 can be lengthened or shortened or rotated or compressed for accurateplacement in the desired location within the lumen. X-ray opaque markers(not shown) can be placed along the prosthesis 20 to assist withplacement of the prosthesis.

In FIG. 9, the screw cap 46 of the pin vise 39 has been loosened so thatthe thin walled tube 15 can been pushed in a proximal direction to movethe proximal attachment sleeve 10 in a proximal direction. When theproximal attachment sleeve 10 no longer surrounds the self expandingstent 21 at the proximal end of the prosthesis 20, the self expandingstent 21 expands. When the stent 21 expands, the hooks or barbs 24 onthe self expanding stent 21 grip into the walls of the lumen of thepatient to hold the proximal end of the prosthesis 20 in place.

At this point, the distal end 42 of the prosthesis 20 is still retainedby the distal attachment section 40, with the loop 43 retained therein.The external sheath 30 has been withdrawn to a position distal of thedistal attachment section 40 to allow the distal end 42 of theprosthesis 20 to expand. At this point, the distal end 42 of theprosthesis 20 can still be moved. Consequently, the prosthesis 20 canstill be rotated or lengthened or shortened or otherwise moved to foraccurate positioning. Where the prosthesis 20 to be deployed is abifurcated graft, the movement at this stage may ensure that the shorterleg is directed in the direction of the contra-iliac artery.

In FIG. 10, the distal end 42 of the prosthesis 20 has been disengagedby removal of the distal trigger wire 44. At this stage, the distaltrigger wire release mechanism 25 and the distal trigger wire 44 can beremoved completely. This removal can be accomplished by passing thedistal wire release mechanism 25 over the pin vise 39 and the connectionmeans 16. The loop 43 of the terminal distal self expanding zigzag stent19 is thus disengaged, and the prosthesis 20 is now free to expand tothe walls of the vessel. At this point, the introducer is ready to beremoved.

In FIG. 11, the first stage of removal is shown. First, the distalattachment section 40 is advanced until the conical tip 23 is receivedin the rear of the proximal attachment sleeve 10. Next, the proximalattachment sleeve 10, the tapered flexible extension 11, and the distalattachment section 40, including the thin walled cannula 22 and theconical tip 23, are removed together, as shown in FIG. 12.

In FIG. 12, the sheath 30 has been advanced to cover the join betweenthe proximal attachment sleeve 10 and the distal attachment section 40.The sheath 30 can be removed with the proximal attachment sleeve 10, thetapered flexible extension 11 and the distal attachment section 40.Alternatively, these items could be removed separately, followed byremoval of the external sheath 30.

Throughout this specification, unless the context requires otherwise,the words “comprise” and “include” and variations such as “comprising”and “including” will be understood to imply the inclusion of an item orgroup of items, but not the exclusion of any other item or group items.

While various embodiments of the invention have been described, it willbe apparent to those of ordinary skill in the art that many moreembodiments and implementations are possible within the scope of theinvention. Furthermore, although various indications have been given asto the scope of this invention, the invention is not limited to any oneof these but may reside in two or more of these combined together.Accordingly, the invention is not to be restricted except in light ofthe attached claims and their equivalents.

1. An introducer for an expandable, endovascular prosthesis, theintroducer comprising: a distal prosthesis positioning mechanismincluding a distal retention section adapted to retain a distal portionof an expandable endovascular prosthesis and a first control member toselectively disengage the distal retention section from the retaineddistal portion of said prosthesis; and a proximal prosthesis positioningmechanism including a cylindrical sleeve adapted to retain saidprosthesis and a second control member to selectively disengage thecylindrical sleeve from said prosthesis; wherein the second controlmember includes a first region coupled to the distal prosthesispositioning mechanism extending longitudinally therefrom, and a secondregion coupled to the first region adapted to selectively and proximallyengage a self expanding stent of said prosthesis to retain the selfexpanding stent in the cylindrical sleeve.
 2. The introducer of claim 1,comprising a tube, wherein the first region is coupled to and extendsproximally from the tube.
 3. The introducer of claim 1, comprising atube, wherein the second region is coupled to and extends proximallyfrom the tube.
 4. The introducer of claim 1, comprising a tube, whereinthe first region is formed from the tube.
 5. The introducer of claim 1,comprising a tube, wherein the second region is formed from the tube. 6.The introducer of claim 1, wherein the first region includes a cannula.7. The introducer of claim 6, comprising a tube, wherein the cannula isformed from the tube.
 8. The introducer of claim 1, wherein the secondregion includes a conical tip.
 9. The introducer of claim 8, comprisinga tube, wherein the conical tip is formed from the tube.
 10. Theintroducer of claim 1, comprising a tube, wherein the distal retentionsection is coupled the tube.
 11. The introducer of claim 1, comprising atube, wherein the distal retention section is formed from the tube. 12.The introducer of claim 1, comprising a control arrangement forcontrolling the length of said prosthesis.
 13. The introducer of claim1, comprising a rotational arrangement by which the relative angularorientation of the proximal and distal portions of said prosthesis canbe adjusted.
 14. An introducer for positioning an expandableendovascular prosthesis, the introducer comprising: a control section tobe maintained external to the patient; a cylindrical sleeve adapted toretain a self expanding stent of an expandable endovascular prosthesis;and a control member including a first region coupled to the controlsection extending longitudinally therefrom, and a second region coupledto the first region to maintain the self expanding stent of saidprosthesis in the cylindrical sleeve until said prosthesis is positionedat a desired site in the lumen.
 15. The introducer of claim 14,comprising a tube coupled between the control section and the firstregion.
 16. The introducer of claim 14, comprising a tube coupledbetween the control section and the second region.
 17. The introducer ofclaim 14, comprising a tube, wherein the first region is formed from thetube.
 18. The introducer of claim 14, comprising a tube, wherein thesecond region is formed from the tube.
 19. The introducer of claim 14,wherein the first region includes a cannula.
 20. The introducer of claim19, comprising a tube, wherein the cannula is formed from the tube. 21.The introducer of claim 14, wherein the second region includes a conicaltip.
 22. The introducer of claim 21, comprising a tube, wherein theconical tip is formed from the tube.
 23. The introducer of claim 14,comprising a control arrangement for controlling the length of saidprosthesis.
 24. The introducer of claim 14, comprising a rotationalarrangement by which the relative angular orientation of the proximaland distal portions of said prosthesis can be adjusted.
 25. Theintroducer of claim 14, comprising a prosthesis positioning mechanismcoupled between the control section and the control member.
 26. Theintroducer of claim 25, wherein the prosthesis positioning mechanismincludes a distal attachment section, the control section comprises atube, and the distal attachment section is coupled to the tube.
 27. Amethod of placing a prosthesis into an internal lumen with an insertionassembly, the method including the steps of: a. inserting the insertionassembly including the prosthesis into the internal lumen; b.withdrawing a sheath from the insertion assembly to expose theprosthesis; c. exerting force on the prosthesis in a proximal directionwith a release mechanism to retain the prosthesis in a prosthesisretention mechanism of the insertion assembly; d. moving the prosthesisretention mechanism proximally away from the release mechanism todisengage the prosthesis from the insertion assembly; d. replacing thesheath onto the insertion assembly; and e. retracting the insertionassembly.